Those of us who manage clinical trials with complex endpoints have elaborated a certain way of thinking. We jump to create charters, define processes, contact experts as soon as the study outline is agreed. But let’s not forget why we do all this. In the vast majority of cases, the studies are intended for a regulatory submission seeking marketing authorization for our drugs. So, what do FDA regulators think about CEC Endpoint adjudication?
Let’ start with the FDA. The agency has rarely mentioned the topic in their numerous guidelines. We all know that FDA language uses recommendation rather than obligation even incases of strong requirement. CEC Endpoint adjudication is no exception to that rule. Below are some quotes from FDA Guidance on the use of endpoint adjudication committees:
Sponsors may also choose to establish a CEC endpoint assessment /adjudication committee(1)
- Cancer drugs: PFS trial design issues (2):
- At a minimum, the assessments should be subjected to a blinded independent adjudication team, generally consisting of radiologists and clinicians.
- An IRC can minimize bias in radiographic interpretation of the radiological findings and independent adjudication of assessments.
- Diabetes: Sponsors should establish an independent cardiovascular endpoints committee to prospectively adjudicate, in a blinded fashion, cardiovascular events during all phase 2 and phase 3 trials (3).
Also, in this video presentation, Ke Liu, MD, PhD Chief of the Oncology branch of the Office of Cellular, Tissue and Gene Therapies of the FDA presents situations when a CEC is useful, discusses potential bias in endpoint assessment, and describes the EAAC charter and operation. VIDEO LINK
In conclusion the FDA expresses the opinion that “Adjudication is an Element of a Successful Development Program” (4).
Read Also this Blog Article: BICR Adjudication: What EMA Think and our Endpoint Adjudication Regulatory summary page
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(1) Guidance for Clinical Trial Sponsors. Establishment and Operation of Clinical Trial Data Monitoring Committees. https://www.fda.gov/media/75398/download
Accessed March 10, 2019.
(2) Clinical Trial Endpoints for the Approval of Cancer Drugs and Biologics, Guidance for Industry, December 2018. https://www.fda.gov/downloads/Drugs/Guidances/ucm071590.pdf
Accessed March 10, 2019.
(3) U.S. Food and Drug Administration. Center for Drug Evaluation and Re- search. Guidance for industry: diabetes mellitus—evaluating cardiovascu- lar risk in new antidiabetic therapies to treat type 2 diabetes. December 2008. Available at: https://www.fda.gov/downloads/Drugs/Guidance- ComplianceRegulatoryInformation/Guidances/ucm071627.pdf.
Accessed March 10, 2019
(4) Karen A. Hicks, M.D., FACC, Medical Officer, FDA, Division of Cardiovascular and Renal Products Center for Drug Evaluation and Research.
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